Process scalability

A change in size on scale-up is not the sole determinant of the seal-ability of a unit operation or process. Scalability depends on the unit operation mechanism(s) or system properties involved. Some mechanisms or system properties relevant to dispersions are listed in Table 2 (59). In a number of instances, size has little or no influence on processing or on system behavior. Thus, scale-up will not affect chemical kinetics or thermodynamics although the thermal effects of a reaction could perturb a system, e.g., by affecting convection (59). Heat or mass transfer within or between phases is indirectly affected by changes in size while convection is directly... 

A change in size on scale-up is not the sole detenninant of the scalability of a unit operation or process. Scalability depends on the unit operation mecha-nism(s) or system properties involved. Some mechanisms or system properties relevant to dispersions are listed in Table 2 [57]. In a number of instances, size has... 

Premises Expression system defined Process scalability Primary definition of process No validation Refinement of operational control parameters Development of scale-down process models for validation Process out-of-limit definition Finalization of process control parameters Fixed and defined process and products Pivotal process validation and characterization studies Validated production process Well-characterized product Robust process ... 

Eliminates aqueous and solvent granulating Facilitates powder flow Uses minimal energy to operate Requires less man-hours to operate Improves drug-dosage weight control Reproduces consistent particle density Produces a dry product that is process scalable... 

Is the process scalable so that it can address small, medium, and large munition finds ... 

Is the process scalable so that it can address small, medium, and large munition finds Yes. Three sizes appear to provide appropriate capability for small, medium, and large quantities. All are transportable to the site. Yes. There are two DAVINCH sizes available and multiple units can be deployed. Large size (70 tons) of smaller DAVINCH (DV45) may make it impractical for small quantity finds, however. Yes. Three detonation chamber sizes are available and several units can be used together to meet throughput requirements. The EDS seems appropriate for small or medium caches. At Pine Bluff Non-Stockpile Facility, several EDSs could have destroyed ca. 1,000 munitions in an acceptable time period. 

Is the process scalable so that it can address small, medium, and large munition finds The process appears to be scalable. Conventional liquid phase reactors are used, and these can be purchased in a wide range of sizes. The process is scalable and can be used for essentially any size find. For very small finds, other technologies may be more appropriate. Alternatively, it can be combined with neutralization, or incineration can be used only to destroy neutralents (e.g., hydrolysates) or neutralents and energetics. RRS and SCANS are intended for use on small quantities of CAIS. Neutralization and hydrolysis can be used for small or large finds. Neutralization and hydrolysis systems can be built at any desired capacity. 

Bockand TK, Kraas U. Experience with the Diosna mini-granulator and assessment of process scalability. Eur J Pharm Biopharm 2001 52 297-303. 

J. A. Board, Jr. et al.. Scalable variants of Multipole-Accelerated Algorithms for Molecular Dynamics Applications, Proceedings, Seventh SIAM Conference on Parallel Processing for Scientific Computing, SIAM, Philadelphia (1995), pp. 295-300. 

Lastly, Strike asked what he thought about the scalability of this process. Can it be upped to 1 mol or more He said he was up to SOmmol and said no decrease in yield was apparent. The time of irradiation also did not need to be any longer than the written protocols. 

The primary lesson from this example is that no process is infinitely scalable. Sooner or later, additional scaleup becomes impossible, and further increases in production cannot be single-train but must add units in parallel. Fortunately for the economics of the chemical industry, the limit is seldom reached. 

Use Scalable Heat Transfer. The feed flow rate scales as S and a cold feed stream removes heat from the reaction in direct proportion to the flow rate. If the energy needed to heat the feed from to Tout can absorb the reaction exotherm, the heat balance for the reactor can be scaled indefinitely. Cooling costs may be an issue, but there are large-volume industrial processes that have Tin —40°C and Tout 200°C. Obviously, cold feed to a PFR will not work since the reaction will not start at low temperatures. Injection of cold reactants at intermediate points along the reactor is a possibility. In the limiting case of many injections, this will degrade reactor performance toward that of a CSTR. See Section 3.3 on transpired-wall reactors. 

One final note While the techniques used here were applied to control temperature In large, semi-batch polymerization reactors, they are by no means limited to such processes. The Ideas employed here --designing pilot plant control trials to be scalable, calculating transfer functions by time series analysis, and determining the stochastic control algorithm appropriate to the process -- can be applied In a variety of chemical and polymerization process applications. 

Rinard dedicated his research to a detailed analysis of methodological aspects of a micro-reactor plant concept which he also termed mini-plant production [85] (see also [4, 9, 10] for a commented, short description). Important criteria in this concept are JIT (Just-in-time) production, zero holdup, inherent safety, modularity and the KISS (keep it simple, stupid) principle. Based on this conceptual definition, Rinard describes different phases in plant development. Essential for his entire work is the pragmatic way of finding process solutions, truly of hybrid character ]149] (miniaturization only where really needed). Recent investigations are concerned with the scalability of hybrid micro-reactor plants and the limits thereof ]149], Expliddy he recommends jointly using micro- and meso-scale components. 

Inherent hazard (e.g., toxicity, stability, reactivity) Cost Renewability Recyclability Size (volume) Scalability Controllability Energy (i.e., total, heating, cooling, recovery, treatment, etc.) Ease of cleaning and maintenance Safety/process safety ... 

To measure the scalability of a process, one needs to define the critical quality attributes and to understand the chemistry and processes involved in order to find the limits of acceptability of these critical attributes, and thus, the limits of the scalability of a process. For a chemical process to be functional at large scale it should also be operationally simple, safe and straightforward. 

The principal considerations involved in design of a process-scale chromatographic purification include scalability, reproducibility, safety, and validatability. Cost factors, however, must by necessity enter into all industrial decisions. Due to the high value-added nature of most biopharmaceuticals, this cost factor is driven by throughput, rather than by capital investment cost. 

The goals of the project were to confirm the molecular weight of hementin, determine the N-terminal amino acid sequence, and provide sufficient purified protein for biochemical studies of the fibrinolytic activity. These goals were all attained. Many of the issues that become important in devising a scalable process were identified, particularly... 

Greenberg, W.A., Varvak, A., Hanson, S.R. el ai (2005) Development of an efficient, scalable, aldolase-catalyzed process for enantioselective synthesis of statin intermediates. Proceedings of the National Academy of Sciences of the United States of America, 101, 5788-5793. 

The culture module greatly facilitated homogeneous distribution of seeded cells and cultivation of a large number of cells under identical conditions. In addition, the module required a smaller volume of medium than standard cell culture systems. Importantly, this modular system provides the great advantages of scalability and safety because cell processing can be performed in a closed system. Thus, the modules facilitate the production of cells that are safe for use in cell transplantation therapies. 

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